Kornimate/medical-research-clean huggingface dataset:
understanding factors in decision making for children with medical complexity

Conditions: Multiple Chronic Conditions; Children with Medical Complexity

Summary: the goal of this clinical trial is to compare different strategies to communicate around potential risks and benefits related to treatment decision making in parents/adult caregivers of children with medical complexity. the objective of this study is to identify the most effective ways to communicate decision-related risks and benefits to improve the quality of caregiver decision making for children with medical complexity. participants will view a video of a simulated clinic visit and related medical information and complete a survey about their experiences. researchers will compare participant survey responses to see if decision quality changes based on the information reviewed by the participant.

children with medical complexity, their caregivers, and their providers face a multitude of complex, high stakes medical decisions throughout their lifetime. best practices for the provision of high quality shared decision making in the care of children with medical complexity do not exist. unique challenges to support decision making for caregivers of children with medical complexity include communication of decision-related risks and benefits and knowledge related to the decision. this study will test the efficacy of various communication techniques in the setting of a simulated patient encounter.

Eligibility criteria:
inclusion criteria: * adult caregiver of a child with medical complexity * english- or spanish-speaking exclusion criteria: * child is diagnosed with neuromuscular scoliosis but has not yet made a decision about whether to undergo spinal fusion.

Keywords: shared decision making health communication patient- and family-centered care
two dose epidural morphine for post-cesarean analgesia

Conditions: Pain; Morphine Adverse Reaction

Summary: the investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled nonsteroidal anti-inflammatory drugs (nsaids). the investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. the primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.

this will be a randomized, double-blinded placebo-controlled study. in this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. it is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. what is not typically carried out is to give a second dose of epidural morphine 3mg. the randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. the primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).

Eligibility criteria:
inclusion criteria: * women undergoing cesarean section under epidural anesthesia. exclusion criteria: * emergent cesarean section * coagulopathy * failed epidural anesthesia or patchy block * general anesthesia * use of epidural chloroprocaine * allergy or contraindication to non-steroidal anti-inflammatory drug (nsaids) * severe opioid side effects * history of chronic opioid use * history of chronic pain * history of obstructive sleep apnea * morbid obesity (body mass index (bmi)\>45 kg/m2) * height under 4' 10" (147 cm) * documented dural puncture by the epidural (tuohy) needle * preeclampsia * other significant medical disease (american society of anesthesiologists (asa) 3 or more).

Keywords: post-cesarean analgesia second dose of epidural morphine after surgery post-operative analgesia self-administered epidural morphine pain management after cesarean
effects of strength training on knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: to understand the effects of leg strengthening exercise, we will study the effects of strength training of the legs in four groups of people: (1) osteoarthritis (oa) with knee pain; (2) oa without knee pain; (3) no oa but elderly with knee pain; and (4) normal elderly with no oa or knee pain. in each of the first three groups, we will look at whether people who do strength training have less pain and/or slower progression of x-ray signs of oa over 30 months than people who perform nonstrengthening, range-of-motion exercises. we are including the fourth group to find out whether people with oa (groups 1 \& 2) have the same response to strength training as healthy elderly people, and whether those with knee pain (groups 1 \& 3) have the same response to training as those without joint pain.

several studies have confirmed that weak leg muscles are associated with osteoarthritis (oa) of the knee. studies of body composition in these people have also shown that, despite being weaker, people with oa have significantly greater muscle mass than those without oa, suggesting that those with oa may have the potential to greatly increase their strength. however, research has not clearly shown whether exercises designed to improve leg strength will decrease the severity of pain or slow the progression of oa based on radiographic (x-ray) analysis. to understand the effects of leg strengthening exercise, we will perform a randomized clinical trial of lower extremity strength training using four subgroups of people: (1) oa with knee pain; (2) oa without knee pain; (3) no oa with knee pain; and (4) normal elderly with no oa or knee pain. in each of the first three groups, we will determine whether people assigned to strength training have lower pain scores and/or slower progression of radiographic changes of oa over 30 months than controls who perform nonstrengthening exercises (i.e., range-of-motion exercises). we are including the fourth group to determine whether those with oa (groups 1 \& 2) exhibit the same response to strength training as healthy elderly people, and whether those with knee pain (groups 1 \& 3) have the same response to training as those without joint pain. we will also prospectively monitor changes in body composition and bone mass, quality of life, and symptoms of depression.

Eligibility criteria:
inclusion criteria: * males and females 60 to 100 years of age exclusion criteria: * knee joint replacement surgery * diabetes mellitus * uncontrollable hypertension * neuropathies of the lower extremity * poor mental cognition (i.e., inability to follow instructions)

Keywords: osteoarthritis (oa) knee radiographic oa strength training physical therapy exercise body composition striated muscle depression radiographic oa with knee pain radiographic oa without knee pain knee pain without radiographic oa normal elderly (no radiographic oa, no knee pain)
effect of ketorolac and remote ischemic preconditioning on renal ischemia-reperfusion injury in patients undergoing partial nephrectomy

Conditions: Renal Cell Carcinoma

Summary: partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney. interruption of renal blood flow via pedicle clamping is often necessary during partial nephrectomy, especially for complex tumors with deep parenchymal invasion. ischemia-reperfusion injury is a complex process involving several mechanisms including renal vasoconstriction, extensive tubular damage and glomerular injury. the investigators will examine the postoperative renal function of patients who received intraoperative ketorolac and remote ischemic preconditioning during partial nephrectomy.


Eligibility criteria:
inclusion criteria: * asa l and ll * age 20-65 * patients undergoing partial nephrectomy exclusion criteria: * preoperative liver or renal dysfunction, * coagulopathy, * chronic alcoholism, * hypersensitivity of nsaid, * history of warfarin, * history of gastric ulcer

Keywords: ketorolac remote ischemic preconditioning partial nephrectomy
evaluation of a multilevel intervention on adult covid-19 and influenza vaccination rate

Conditions: COVID-19 Immunisation; Influenza Vaccine

Summary: the study will test two tactics to improve uptake of two vaccines in adults. the vaccines prevent covid-19 and influenza. both are common and harmful. most adults do not get either vaccine. this is despite strong recommendations that all adults get both vaccines. the study will involve adult patients at eight mayo clinic primary care practices in rochester and kasson. the study will test the two tactics together. four clinics will get the two tactics. the other four clinics will not. the study will randomly assign the two tactics to the clinics. one tactic is to send a letter by us mail to the patient. the letter will state strong recommendations on getting both vaccines now. it will tell patients how to get the vaccines now. the second tactic is to send monthly emails to clinicians. it will remind them to use every visit to vaccinate patients against covid-19 and influenza. the study will compare the uptake of the two vaccines after six months in the clinics with and without the two tactics.


Eligibility criteria:
inclusion criteria: * patients 19 years and older * patients empaneled to 1 of 8 adult primary care practices as of september 2024 exclusion criteria: * patients 18 years or younger * patients not empaneled to 1 of 8 adult primary care practices as of september 2024

Keywords: adult vaccination influenza vaccines covid-19 vaccines primary health care reminder systems clinician communication patient communication
multiple-biomarker approach for individualized treatment of heart failure with preserved ejection fraction

Conditions: Heart Failure with Preserved Ejection Fraction; Heart Failure, Diastolic; Chronic Heart Failure

Summary: the primary objective is to investigate the association between temporal evolutions of blood biomarkers and clinical adverse events, in order to produce a dynamic, individual, and accurate prediction model for patients with hfpef. moreover several secondary objectives will be investigated.

this is a prospective, observational multi-center cohort study which will be conducted at the cardiology departments of the erasmus medical centre (emc) as well as five other hospitals. a total of 200 hfpef patients will be included in the study via the outpatient clinics. the follow-up period will constitute a minimum of 2 years and a maximum of 3.5 years. clinical data will be collected at baseline and blood samples will be collected at baseline and subsequently every 6 months.

Eligibility criteria:
inclusion criteria: * age of 18 years or older * capable of understanding and signing informed consent * a diagnosis of hfpef according to the hfa-peff diagnostic algorithm of the esc or/and a high (90%) probability of hfpef according to the h2fpef score, i.e. a score of 6 or higher. exclusion criteria: * history of lvef ≤40% * scheduled for surgery or intervention for both coronary and non-coronary indication within 6 months of inclusion * impaired renal function, defined as egfr \< 20 ml/min/1.73 m2 (ckd-epi) or requiring dialysis at the time of screening * acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening * copd gold stage iv * congenital heart disease * pregnancy * coexistent condition with life expectancy of \<1 year * unlikely to appear at all scheduled follow-up visits * linguistic barrier

Keywords: hfpef heart failure preserved ejection fraction biomarkers
a two year longitudinal clinical study of neurocognitive and psychiatric symptoms in post covid-19 patients

Conditions: COVID-19

Summary: the prospective, longitudinal, open observational study monitors patients with cognitive and neuropsychological symptoms after covid-19 infection, in a longitudinal manner to see how the disease has affected their physical, psychological and cognitive function, their ability to be active, return to work, their health-related quality of life in correlation with potential diagnostic and prognostic markers.

the aim is to increase knowledge of the underlying biological processes; how biomarkers correlate with degree of symptoms, mapping their role as diagnostic markers over time (24 months). the investigators follow up to 100 study participants with post-acute sequelae of sars-cov-2 infection (pasc) for 24 months, measure their physical, psychological and neurocognitive symtoms and how they change over time (three visits: baseline, 12 months, 24 months) in correlation with biomarkers in blood, cerebrospinal fluid and faeces samples as well as neuroradiological changes on mri (baseline, 24 months). knowledge about the late effects of covid-19 and its pathogenesis is still unknown. the findings of the study can therefore be used as a guidance for future actions in healthcare and, in the best case, can lead to a possible, either curative or symptom-relieving, treatment.

Eligibility criteria:
inclusion criteria: * neurocognitive symptoms after lab-verified covid-19 infection exclusion criteria: * severe illness e.g cancer with a short expected survival time * ongoing alcohol abuse * ongoing drug abuse.

Keywords: covid-19 sequelae cognitive symptoms neuropsychological symptoms neuropsychological testing biomarkers cerebrospinal fluid microbiota
a phase 3 study comparing carelizumab plus nab-paclitaxel and apatinib, carelizumab plus nab-paclitaxel, and nab-paclitaxel in patients with advanced triple negative breast cancer.

Conditions: Breast Cancer; Triple Negative Breast Cancer

Summary: this randomized, open-label phase 3 study will evaluate the safety and efficacy of carelizumab (an engineered anti-programmed death-ligand 1 \[pd-1\] antibody) in combination with nab-paclitaxel and apatinib, carelizumab plus nab-paclitaxel, and nab-paclitaxel in patients with unresectable locally advanced or metastatic triple negative breast cancer. participants will be randomized in a 1:1:1 ratio to arm a (carelizumab + nab-paclitaxel + apatinib), arm b (carelizumab + nab-paclitaxel), or arm c (nab-paclitaxel).


Eligibility criteria:
inclusion criteria: * ecog performance status of 0-1. * expected lifetime of not less than three months * metastatic or locally advanced, histologically documented tnbc (absence of her2, er, and pr expression) * cancer stage: locally advanced or metastatic breast cancer; locally advanced breast cancer not amenable to radical resection. * no prior systemic antitumor therapy for metastatic triple-negative breast cancer. * adequate hematologic and organ function * measurable disease according to response evaluation criteria in solid tumors v1.1 (recist v1.1) exclusion criteria: * known central nervous system (cns) disease. * previously received anti-vegfr small molecule tyrosine kinase inhibitors or anti-pd-1/pd-l1 antibody. * a history of bleeding, any serious bleeding events. * uncontrolled pleural effusion, pericardial effusion. * malignancies other than tnbc within 5 years prior to randomisation, or ascites requiring recurrent drainage procedures * history of interstitial pneumonitis. * severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including tb, etc. * prior allogeneic stem cell or solid organ transplantation. * history of autoimmune disease * active hepatitis b or hepatitis c * pregnancy or lactation. * peripheral neuropathy grade ≥2. * participants with poor blood pressure control; * myocardial infarction incident within 6 months prior to randomisation; * treatment with systemic immunostimulatory agents within 4 weeks prior to randomisation * treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation

Keywords: shr-1210 pd-1
feasibility and diagnostic accuracy of myocardial spect using early imaging protocol

Conditions: Coronary Artery Disease; Atherosclerosis

Summary: encouraged by the recent data published ,the investigators think that a waiting time of 10 minutes is feasible while preserving diagnostic accuracy and would like to assess the feasibility and diagnostic efficacy of w10 compared with w30 imaging in a pilot study. by combining w10 imaging with half-time acquisition, the time of the technetium-99m myocardial perfusion imaging procedure could be shortened by at least 50%, lasting only 40 minutes for w10 (10-minute waiting) imaging compared with 90 minutes for w30 imaging (30-minute waiting). the investigators hypothesize that (1) w10 mpi is clinically feasible and tolerable by the patients, that (2) w10 mpi provides high image quality and that (3) w10 mpi provides diagnostic accuracy comparable to w30 mpi.


Eligibility criteria:
inclusion criteria: * men and women ≥18 and ≤ 89 years of age of any race /ethnicity * patient has undergone or is being scheduled for a clinically indicated cardiaccath with or without angioplasty * patient may have suffered myocardial infarction more than 3 days before t99m-mpi * patient may have undergone percutaneous transluminal coronary angioplasty (ptca) or coronary stent placement more than 3 days prior to t99m-myocardial perfusion imaging (mpi) * interval between t99m-mpi and cardiaccath is within 30 days * females cannot be pregnant or lactating * women of no child-bearing potential (post-menopausal defined as amenorrhea ≥ 12 consecutive months, or because they have undergone successful surgical sterilization and deny current history of pregnancy and nursing). these subjects do not require serum pregnancy test on the day of the study * women of childbearing potential will require a negative serum pregnancy test, performed on the day of the study * provide signed informed consent prior to undergoing the study procedures exclusion criteria: * patients less than 18 and ≥89 years of age * patient has been involved in any other investigative, radioactive research procedure within 7 days and during the study participation period * history of 2nd or 3rd degree atrio-ventricular-block, or sinus node dysfunction unless the patients have a functioning artificial pacemaker * current ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter * current unstable angina or cardiovascular instability * current history of exacerbated chronic obstructive pulmonary disease (copd) or asthma * known hypersensitivity or contraindication to regadenoson or aminophylline * use of caffeinated substance, dipyridamole-containing medication, aminophylline, or xanthines containing medication (e.g. theophylline) within the 12 hours prior to lexiscan administration

Keywords: stable coronary artery disease
a study of brexanolone for acute respiratory distress syndrome (ards) due to coronavirus disease 2019 (covid-19)

Conditions: Acute Respiratory Distress Syndrome; COVID-19

Summary: the purpose of this study was to evaluate the efficacy and safety of brexanolone in participants on ventilator support for acute respiratory distress syndrome (ards) due to covid-19.


Eligibility criteria:
inclusion criteria: * participant was confirmed positive for the novel coronavirus responsible for sars-cov-2 (severe acute respiratory syndrome coronavirus 2) infection as determined by polymerase chain reaction (pcr) at screening * participant had a presumptive diagnosis of ards at screening and partial pressure of arterial oxygen (pao2)/fraction of inspired oxygen (fio2) (ratio of partial pressure of arterial oxygen to fraction of inspired oxygen \[pf ratio\]) less than (\<) 300 prior to randomization * participant was intubated and receiving mechanical ventilation prior to randomization * participants must had initiated mechanical ventilation within 48 hours prior to screening, or had an immediate clinical plan for such intervention at time of screening * participant was likely to survive, in the opinion of the investigator, for at least 72 hours from the time of screening exclusion criteria: * participant had fulminant hepatic failure at screening * participant had end stage renal disease at screening * participant had a known allergy to progesterone, allopregnanolone, or any excipients in the brexanolone injection * participant was concurrently participating in another clinical trial for an investigational product or device at screening
preoperative acetaminophen- caffeine- codeine combination and anaesthetic success in patients with acute pulpitis

Conditions: Symptomatic Irreversible Pulpitis

Summary: the aim of the study is to evaluate the effect of preoperative administration of acetaminophen- codeine -caffeine combination on the success of the inferior alveolar nerve block versus bacetaminophen alone or placebo in patients with symptomatic irreversible pulpitis.

after ensuring eligibility, patients will be given premedication 1hr before treatment,which will be done in single visit. after 1 hour, pretreatment pain "pain after administration of analgesic or placebo" will be recorded using 0-10 numerical rating scale (nrs) . local anesthesia will, then, be done through inferior alveolar nerve block using 1.8 ml mepivacaine. the teeth will be isolated using rubber dam and access cavity will be prepared using #2 high-speed round bur. the patients will be asked to rate their pain on the nrs. the degree of pain during access preparation and/or instrumentation will be recorded. success will be defined as no pain or mild pain during endodontic access preparation and/or instrumentation. any pain more than no pain or mild pain will considered a failure. the patients will be instructed to return after 2 days to complete the treatment procedures.

Eligibility criteria:
inclusion criteria: 1. patients aging between 18-50 years old. 2. patients with mandibular molar with symptomatic irreversible pulpitis. 3. systemically- healthy patients. 4. patients who agree to attend for recall appointments and provide a written consent. exclusion criteria: 1. pregnant or lactating female patients. 2. patients had allergies to any of test medications. 3. patients had taken analgesics medication within the last 6 hours. 4. moderate or severe marginal periodontitis i.e. pocket probe\>3mm. 5. non-restorable teeth, teeth with necrotic pulp, pulp polyp, tooth tender to percussion, root resorption or root canal calcification, periapical disease

Keywords: postoperative pain paracetamol placebo single visit root canal treatment